FDA 510(k) Application Details - K112101

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K112101
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	POLYMED THERAPEUTICS, INC 27001 LA PAZ ROAD, SUITE 266B MISSION VIEJO, CA 92691 US Other 510(k) Applications for this Company
Contact	TERRI WALLACE Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	JHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2011
Decision Date	07/17/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review